Contrast-Enhanced US of Spleen, Liver and Kidney | NCT00190281

Studies
Contrast-Enhanced US of Spleen, Liver and Kidney

NCT00190281

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Dec 13, 2005Estimated

Enrollment

Phase

Not provided

Conditions

Malaria
Pyelonephritis
Bacterial Infections

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2005

Last Update Posted Date

Dec 13, 2005Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Not provided

Description Module

Brief Summary

To evaluate the changes in the microcirculation of the liver, kidney and spleen during acute infection in patients with malaria (cohorts 1 and 3) and other infectious diseases such as acute pyelonephritis at day 0 (within 8 hours of the treatment start), day 2 to 4 and day 28-32, using functional US with continuous infusion of a contrast agent (SonoVue, Bracco, Italy).

Study hypothesis: malaria patients should exhibit a different pattern of enhancement, particularly when quantitative measurements of the SU signals is performed with destruction reperfusion kinetics.

Detailed Description

Three cohortes will be studied: cohorte 1 infection at Plasmodium falciparum (24 patients), cohorte 3 infection at Plasmodium vivax, ovale or malariae (5 patients) and cohorte 2 other infectious diseases such as acute pyelonephritis (24 patients).

Study hypothesis: malaria patients should exhibit a different pattern of enhancement, particularly when quantitative measurements of the SU signals is performed with destruction reperfusion kinetics.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Social security number
Age over 18
acute malaria infection or other infectious diseases
Inpatients
Signed informed consent form

Exclusion Criteria:

Pregnancy
Criteria of bad tolerance of infection
Treatment started for more than 8 hours
Lack of cooperation
History of splenectomy, hematological disease, cirrhosis with portal hypertension, splenomegaly
Medical treatment with beta blocker, diuretic, immunodepression drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Olivier Lortholary, MD PhD	Contact	33-1-44-49-41-42		olivier.lortholary@nck.ap-hop-paris.fr

Overall Officials

Name	Affiliation	Role
Jean-Michel Correas, MD PhD	Hôpital Necker-Enfants Malades	Principal Investigator
Pierre Buffet, MD PhD	Centre Médical - Institut Pasteur	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Adult Radiology, Necker University Hospital	Recruiting	Paris	Île-de-France Region	75015	France

Condition Browse Module

MeSH Terms

ID	Term
D008288	Malaria
D011704	Pyelonephritis
D001424	Bacterial Infections

Ancestor Terms

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases

Browse Leaves

Not provided

Browse Branches

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